Quality Control professional overseeing manufacturing processes in Netherlands production. Monitoring production yields and driving quality improvements through root cause and failure analysis.
About the role
- Senior Software Quality Engineer supporting medical digital health projects with a focus on software quality and compliance in a hybrid role.
Responsibilities
- Designed and tested prototypes and components, applying engineering principles to meet sub-system requirements and support product development
- Conducted root-cause analysis and problem-solving, evaluating solutions against technical and regulatory criteria
- Translated design inputs into engineering specifications, contributing to component-level and system-level architecture and documentation
- Developed software components, estimated development resources, and led code reviews to ensure alignment with design standards and best practices
- Collaborated cross-functionally with R&D, Quality, Regulatory, and Marketing teams to drive project success and ensure compliance with design controls and risk management processes
- Created and maintained engineering documentation, including Design History Files, in accordance with medical device regulatory standards
- Demonstrated strong understanding of clinical use cases, customer needs, and product requirements to inform design decisions
- Adapted quickly to new systems and processes, showing initiative, ownership, and the ability to prioritize tasks with minimal supervision
Requirements
- Bachelor’s degree in a science or engineering
- Minimum of 2+ years of experience working in a highly regulated industry in following cGMP and GDP regulations in the areas of Research & Development (R&D), Quality (QA/QC), Software Engineering, Information Technology, Healthcare IT or Systems Engineering
- Bachelor’s degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science (preferred)
- Experience working through software lifecycle processes (Agile SAFe/Waterfall)
- Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation
- Previous employment at leading technology companies such as Amazon, Google, Microsoft, or similar, demonstrating strong technical skills
- Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and/or Digital Health Systems and Telehealth Solutions
- Knowledge from using Application Lifecycle Management /Traceability tools.
Benefits
- salary plus bonus eligible
- benefits
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